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MALAYSIA: MDA Announced the Fifth Edition on the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products – March/April 2023

MALAYSIA: MDA Announced the Fifth Edition on the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products – March/April 2023

  • 2023-03-27 09:16:15

The Medical Device Authority (MDA) published the Fifth Edition Guidance Document, "Guideline for Registration of Drug-Medical Device and Medical Devie-Drug Combination Products", on January 03, 2023. This document is intended to provide information on how to apply for an endorsement letter, post-approval changes/variation applications for ancillary components, adverse drug reactions and incident reporting for the registered combination product.

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PHILIPPINES: Updated Draft Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices – March/April 2023

PHILIPPINES: Updated Draft Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices – March/April 2023

  • 2023-03-27 08:52:43

PFDA presented a draft of the updated guidelines on obtaining a special permit for restricted use of unregistered drug and medical device products. In addition to previous patient conditions laid out by previous regulations, this new guidance widens the product scope to vaccines and the diseases to include those that may result in the patient's permanent disability.

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China: NMPA Announcement on Issuing the "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety" (2022 No. 124) –February/March 2023

China: NMPA Announcement on Issuing the "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety" (2022 No. 124) –February/March 2023

  • 2023-02-23 02:05:29

In order to supervise medical device registrants taking the responsibilities for medical device quality and safety, NMPA has issued the so-called "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety".

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MALAYSIA: MDA Announces New Guideline On How to Submit an Application for Registration of A Refurbished Medical Device – February/March 2023

MALAYSIA: MDA Announces New Guideline On How to Submit an Application for Registration of A Refurbished Medical Device – February/March 2023

  • 2023-02-23 01:35:01

The Medical Device Authority (MDA) published the First Edition Guideline Document “How To Submit An Application For Registration Of A Refurbished Medical Device” (MDA/GL/10) on January 11, 2023. The MDA created this guidance document to assist the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its regulations.

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USA: US Medical Device Classification Update: Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions & The Prognostic Test for Assessment of Liver Related Disease Progression – February/March 2023

USA: US Medical Device Classification Update: Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions & The Prognostic Test for Assessment of Liver Related Disease Progression – February/March 2023

  • 2023-02-22 11:03:38

According to US FDA's review request for devices, the digital therapy device to reduce sleep disturbance for psychiatric conditions, and the prognostic tests for assessment of liver-related disease progression, will require special control (Class II). Thus, in the future, the US FDA will refer to the class II level to review these two kinds of devices.

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